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Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review

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dc.contributor.author Polhemus, Ashley Marie
dc.contributor.author Bosch de Basea i Gómez, Magda, 1982-
dc.contributor.author Delgado Ortiz, Laura
dc.contributor.author García Aymerich, Judith
dc.contributor.author Koch, Sarah
dc.contributor.author Frei, Anja
dc.date.accessioned 2021-01-25T07:31:04Z
dc.date.available 2021-01-25T07:31:04Z
dc.date.issued 2020
dc.identifier.citation Polhemus AM, Bergquist R, Bosch de Basea M, Brittain G, Buttery SC, Chynkiamis N et al. Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review. BMJ Open. 2020; 10(7):e038704. DOI: 10.1136/bmjopen-2020-038704
dc.identifier.issn 2044-6055
dc.identifier.uri http://hdl.handle.net/10230/46260
dc.description.abstract Introduction: Advances in wearable sensor technology now enable frequent, objective monitoring of real-world walking. Walking-related digital mobility outcomes (DMOs), such as real-world walking speed, have the potential to be more sensitive to mobility changes than traditional clinical assessments. However, it is not yet clear which DMOs are most suitable for formal validation. In this review, we will explore the evidence on discriminant ability, construct validity, prognostic value and responsiveness of walking-related DMOs in four disease areas: Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease and proximal femoral fracture. Methods and analysis: Arksey and O'Malley's methodological framework for scoping reviews will guide study conduct. We will search seven databases (Medline, CINAHL, Scopus, Web of Science, EMBASE, IEEE Digital Library and Cochrane Library) and grey literature for studies which (1) measure differences in DMOs between healthy and pathological walking, (2) assess relationships between DMOs and traditional clinical measures, (3) assess the prognostic value of DMOs and (4) use DMOs as endpoints in interventional clinical trials. Two reviewers will screen each abstract and full-text manuscript according to predefined eligibility criteria. We will then chart extracted data, map the literature, perform a narrative synthesis and identify gaps. Ethics and dissemination: As this review is limited to publicly available materials, it does not require ethical approval. This work is part of Mobilise-D, an Innovative Medicines Initiative Joint Undertaking which aims to deliver, validate and obtain regulatory approval for DMOs. Results will be shared with the scientific community and general public in cooperation with the Mobilise-D communication team. Registration: Study materials and updates will be made available through the Center for Open Science's OSFRegistry (https://osf.io/k7395).
dc.description.sponsorship The MOBILISE-D project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820 820. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). HD is a postdoctoral research fellow of the FWO-Flanders. JGA, MBdB, LDO and SK acknowledge support from the Spanish Ministry of Science, Innovation and Universities through the 'Centro de Excelencia Severo Ochoa 2019–2023' Programme (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Programme.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher BMJ Publishing Group
dc.relation.ispartof BMJ Open. 2020; 10(7):e038704
dc.rights © Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
dc.title Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1136/bmjopen-2020-038704
dc.subject.keyword Parkinson-s disease
dc.subject.keyword Chronic airways disease
dc.subject.keyword Geriatric medicine
dc.subject.keyword Multiple sclerosis
dc.subject.keyword Orthopaedic & trauma surgery
dc.subject.keyword Telemedicine
dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/820820
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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